Label: TROPIC SPORT MINERAL SUNSCREEN SPF 30- titanium dioxide, zinc oxide lotion

  • NDC Code(s): 70884-409-03, 70884-409-07
  • Packager: X3EM Brands LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 22, 2021

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Titanium Dioxide, 4.5%

    Zinc Oxide, 8.6%

  • PURPOSE

    Sunscreen

  • INDICATIONS & USAGE

    Uses

     helps prevent sunburn

     if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

  • WARNINGS

    For external use only

  • DO NOT USE

    Do not use on damaged or broken skin

  • WHEN USING

    When using this product keep out of eyes. Rinse with water to remove

  • STOP USE

    Stop use and ask a doctor if rash occur

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away

  • INDICATIONS & USAGE

    Directions

     apply liberally 15 minutes before sun exposure

     reapply: after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours

    Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF of 15 or higher and other sun protection measures including:

     limit time in the sun, especially from 10 a.m.– 2 p.m.

     wear long-sleeved shirts, pants, hats, and sunglasses

  • USE IN SPECIFIC POPULATIONS

     children under 6 months of age: Ask a doctor

  • OTHER SAFETY INFORMATION

    Other information

     protect the product in this container from excessive heat and direct sun

  • INACTIVE INGREDIENT

    Inactive ingredients: Water/Aqua/Eau, Caprylic/Capric Triglyceride, Glycerin, Cetearyl Alcohol, Steareth-2, VP/Hexadecene Copolymer, Steareth-21, Dimethicone, Polyhydroxystearic Acid, Aloe Barbadensis Leaf Extract, Camellia Oleifera Leaf Extract, Pleiogynium Timoriense Fruit Extract, Podocarpus Elatus Fruit Extract, Terminalia Ferdinandiana Fruit Extract, Adansonia Digitata Seed Oil, Astrocaryum Tucuma Seed Butter, Macadamia Ternifolia Seed Oil, Dipotassium Glycyrrhizate, Alumina, Stearic Acid, Sodium Stearoyl Glutamate, Triethoxycaprylylsilane, Propanediol, Caprylhydroxamic Acid, Xanthan Gum, Caprylyl Glycol, Fragrance (Parfum).

  • QUESTIONS

    Questions or comments? Call 1-844-484-2096 or www.tropicsport.com

  • PRINCIPAL DISPLAY PANEL

    TSSPF30

  • INGREDIENTS AND APPEARANCE
    TROPIC SPORT MINERAL SUNSCREEN  SPF 30
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70884-409
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.5 mg  in 100 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE8.6 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    STEARETH-2 (UNII: V56DFE46J5)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    STEARETH-21 (UNII: 53J3F32P58)  
    PODOCARPUS ELATUS FRUIT (UNII: R4N1M6CZCY)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ADANSONIA DIGITATA SEED OIL (UNII: 77MKL7AR5I)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70884-409-0388 mg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/08/201904/08/2024
    2NDC:70884-409-07192 mg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/08/201904/08/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/08/201904/08/2024
    Labeler - X3EM Brands LLC (080315280)